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INDICATIONS:

Rasuvo is indicated for the:

•Management of adults with severe, active rheumatoid
arthritis (RA) (ACR criteria) or children with active polyarticular juvenile idiopathic
arthritis (pJIA), who are intolerant of or had an inadequate response to first‑line
therapy, including full dose non‑steroidal anti‑inflammatory agents (NSAIDs).

•Symptomatic control of severe, recalcitrant, disabling
psoriasis in adults who are not adequately responsive to other forms of therapy,
but only when the diagnosis has been established, as by biopsy and/or after dermatologic
consultation. It is important to ensure that a psoriasis "flare" is not
due to an undiagnosed concomitant disease affecting immune response.

Limitations of Use
Rasuvo is not indicated for treatment of neoplastic diseases.

This product includes the following Boxed Warning:

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO‑FETAL TOXICITY AND DEATH

Rasuvo should be used only by physicians whose knowledge and experience include
the use of antimetabolite therapy. Because of the possibility of serious toxic reactions
(which can be fatal), Rasuvo should be used only in patients with psoriasis or rheumatoid
arthritis with severe, recalcitrant, disabling disease which is not adequately responsive
to other forms of therapy. Deaths have been reported with the use of methotrexate
in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should
be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities.
Patients should be informed by their physician of the risks involved and be under
a physician's care throughout therapy.

Methotrexate has been reported to cause fetal death and/or congenital anomalies.
Therefore, Rasuvo is not recommended for females of childbearing potential unless
there is clear medical evidence that the benefits can be expected to outweigh the
considered risks. Rasuvo is contraindicated in pregnant women.

Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia,
and gastrointestinal toxicity have been reported with concomitant administration
of methotrexate (usually in high dosage) along with some nonsteroidal anti‑inflammatory
drugs (NSAIDs).

Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after
prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually
transient and asymptomatic, and also do not appear predictive of subsequent hepatic
disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis
and cirrhosis have been reported; these latter lesions may not be preceded by symptoms
or abnormal liver function tests in the psoriasis population. For this reason, periodic
liver biopsies are usually recommended for psoriatic patients who are under long‑term
treatment. Persistent abnormalities in liver function tests may precede appearance
of fibrosis or cirrhosis in the rheumatoid arthritis population.

Methotrexate‑induced lung disease, including acute or chronic interstitial pneumonitis,
is a potentially dangerous lesion, which may occur acutely at any time during therapy
and has been reported at low doses. It is not always fully reversible and fatalities
have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may
require interruption of treatment and careful investigation.

Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic
enteritis and death from intestinal perforation may occur.

Malignant lymphomas, which may regress following withdrawal of methotrexate, may
occur in patients receiving low‑dose methotrexate and, thus, may not require cytotoxic
treatment. Discontinue Rasuvo first and, if the lymphoma does not regress, appropriate
treatment should be instituted.

Like other cytotoxic drugs, methotrexate may induce "tumor lysis syndrome"
in patients with rapidly growing tumors.

Severe, occasionally fatal, skin reactions have been reported following single or
multiple doses of methotrexate. Reactions have occurred within days of oral, intramuscular,
intravenous, or intrathecal methotrexate administration. Recovery has been reported
with discontinuation of therapy.

Methotrexate given concomitantly with radiotherapy may increase the risk of soft
tissue necrosis and osteonecrosis.

CONTRAINDICATIONS:

Rasuvo is contraindicated in the following:

•Pregnancy: Rasuvo can cause fetal
death or teratogenic effects when administered to a pregnant woman. Rasuvo is contraindicated
in pregnant women. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the potential
hazard to the fetus.

•Nursing Mothers: Because of the potential
for serious adverse reactions from methotrexate in breast fed infants, Rasuvo is
contraindicated in nursing mothers.

•Hypersensitivity: Patients with a
known hypersensitivity to methotrexate. Severe hypersensitivity reactions have been
observed with methotrexate use.

WARNINGS AND PRECAUTIONS

•Organ System Toxicity: Rasuvo has
the potential for serious toxicity. Rasuvo should be used only by physicians whose
knowledge and experience include antimetabolite therapy. Because of the possibility
of severe toxic reactions (which can be fatal), Rasuvo should be used only in patients
with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease
which is not adequately responsive to other forms of therapy.

•Embryo‑Fetal Toxicity: Methotrexate
has been reported to cause fetal death and/or congenital anomalies. Rasuvo is not
recommended for females of childbearing potential unless there is clear medical
evidence that the benefits can be expected to outweigh the considered risks. Rasuvo
is contraindicated in pregnant women with psoriasis or rheumatoid arthritis. Exclude
pregnancy before treatment. Females should be counseled on the serious risks to
the fetus should they become pregnant while undergoing treatment. Avoid pregnancy
if either partner is receiving Rasuvo. Advise males to avoid pregnancy for a minimum
of three months after therapy and females to avoid pregnancy for at least one ovulatory
cycle after therapy.

•Effects on Reproduction: Methotrexate
has been reported to cause impairment of fertility, oligospermia and menstrual dysfunction
in humans, during and for a short period after cessation of therapy.

•Laboratory Tests: Patients undergoing
Rasuvo therapy should be closely monitored so that toxic effects are detected promptly.
Baseline assessment should include a complete blood count with differential and
platelet counts, hepatic enzymes, renal function tests and a chest X‑ray.

•Risks from Improper Dosing: The physician
and/or pharmacist should emphasize to the patient that Rasuvo is administered once
weekly and mistaken daily use has led to fatal toxicity.

•Dizziness and Fatigue: May impair
ability to drive or operate machinery.

•Malignant Lymphomas: Non‑Hodgkin's
lymphoma and other tumors have been reported in patients receiving low‑dose oral
methotrexate. However, there have been instances of malignant lymphoma arising during
treatment with low‑dose methotrexate, which have regressed completely following
withdrawal of methotrexate, without requiring active anti‑lymphoma treatment. Discontinue
Rasuvo first and, if the lymphoma does not regress, appropriate treatment should
be instituted.

DRUG INTERACTIONS

•Aspirin, NSAIDs, and Steroids: Concomitant
use may elevate and prolong serum methotrexate levels, resulting in deaths from
severe hematologic and gastrointestinal toxicity.

•Proton Pump Inhibitors (PPIs): Concomitant
use of some PPIs may elevate and prolong serum levels of methotrexate and cause
increased toxicity.

•Oral Antibiotics: Certain oral antibiotics
may decrease intestinal absorption of methotrexate or interfere with enterohepatic
circulation by inhibiting bowel flora and suppressing metabolism of the drug by
bacteria. Use of Rasuvo with penicillins should be carefully monitored.

•Hepatotoxins: Patients receiving concomitant
therapy with Rasuvo and other potential hepatotoxins should be closely monitored
for possible increased risk of hepatotoxicity.

•Theophylline: Methotrexate may decrease
the clearance of theophylline, therefore theophylline levels should be monitored.